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Study of Intraocular Concentrations (Aqueous Humor, Vitreous Humor) of Antibiotics After Local and/or Systemic Administration in Endophthalmitis (CINEBIOPHTA)

Primary Purpose

Endophthalmitis

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pharmacokinetic and pharmacodynamic study of antibiotics used in severe endophthalmitis from samples taken from treated patients
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endophthalmitis focused on measuring intraocular concentrations of antibiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female > 18 years old
  • Francophone
  • Patients referred to emergencies by an ophthalmologist or doctor, or patients already hospitalized, with a unfavourable course 48 hours after introduction of broad spectrum probabilistic antibiotic therapy for the following situations:

    • Cataract surgery
    • Vitreoretinal surgery
    • Intravitreal injection [anti-VEGF for the treatment of AMD, dexamethasone (Ozurdex®) for the treatment of cystoid macular edema]
    • Physical signs presence of intraocular inflammation (Tyndall, hypopyon, cyclic membrane, hyalite)
    • Presence of functional signs (Decreased Visual Acuity)
  • Patients for whom a management re-evaluation is essential with obligation of new intraocular samples.
  • Patient affiliated to social security or, failing that, to another health insurance system

Exclusion Criteria:

  • Patient under guardianship or curators
  • Patient deprived of liberty
  • Participation refusal in the study

Sites / Locations

  • Groupe Hospitalier Paris Saint Joseph

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intraocular antibiotic concentrations determination

Arm Description

In the event that the patient develops unfavourably, the ophthalmologist include the patient in the trial. The patient is reviewed at 48 hours after the introduction of probabilistic antibiotic therapy for clinical reassessment and the return of microbiological test results. Following this inclusion, the new samples will be taken when the patient passes through the operating room for the treatment of his pathology as part of the care. Ophthalmologists may have to adapt the patient's management (i.e. adjustment of antibiotic therapy) as part of their usual care routine. An anterior chamber puncture and a vitrectomy are performed. Eye fluids collected as part of the treatment are sent for analysis.

Outcomes

Primary Outcome Measures

Determination of the concentrations of the various antibiotics in the media tested (aqueous and vitreous humours)
Determination of the concentrations of the various antibiotics in the media tested (aqueous and vitreous humours) by liquid chromatography coupled with a high-resolution mass spectrometer (HPLC-HRMS).

Secondary Outcome Measures

Number of aqueous or vitreous humor samples collected by puncture from treated patients that can be used analytically

Full Information

First Posted
May 27, 2019
Last Updated
March 6, 2023
Sponsor
Fondation Hôpital Saint-Joseph
Collaborators
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
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1. Study Identification

Unique Protocol Identification Number
NCT03968341
Brief Title
Study of Intraocular Concentrations (Aqueous Humor, Vitreous Humor) of Antibiotics After Local and/or Systemic Administration in Endophthalmitis
Acronym
CINEBIOPHTA
Official Title
Intraocular Concentrations Study (Aqueous Humor, Vitreous Humor) of Antibiotics After Local and/or Systemic Administration in Endophthalmitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
June 8, 2022 (Actual)
Study Completion Date
December 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph
Collaborators
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Endophthalmitis is an intraocular inflammation due to a serious infection of bacterial, fungal or parasitic origin, involving visual prognosis if it is not treated in time and correctly. Despite the eye isolation from the rest of the body, germs can enter the eye either exogenously, during open globe surgery, following perforating eye trauma, or following anti-VEGF antibodies intravitreal injection, or other drugs such as corticosteroids for example, or by endogenous route, haematogenic as part of sepsis, usually during immunodepression. Post-operative endophthalmitis is the most feared complication following any endo-ocular surgery. It can be acute, occurring within 6 weeks post-operatively or delayed as after poor healing, or on a glaucoma filtration bubble. Endophthalmitis after cataract surgery is a complication with a low incidence of (0.030 to 0.047%) but which, due to interventions number carried out (830,000 in 2016, in France), appears significant. There are factors that favour endophtalmitis occurrence such as a vitreous exit from eyeball during surgical procedure, poor scar coaptation, premature removal of sutures, etc... They condition emergency care. Early diagnosis and appropriate treatment are essential for safeguarding the eye and its function. Therefore, therapeutic management requires endo-ocular sampling in front of any suspicion of endophtalmitis, to be done before any treatment, to carry out microbiological analysis (direct examination on slide, culture, universal and/or targeted PCR, antibiotic susceptibility test). Vitreous puncture is more contributive than anterior chamber puncture, underlining need for these two samples to identify the responsible germ. Once samples have been taken, a broad-spectrum antibiotic therapy introduction must be performed intra-vitreously combined with systemic and local administration. Intravitreal injections allow treatment to be provided at effective concentrations directly at the infection site. On the other hand, toxic risks must be taken into account, especially since the protocol may require multiple intravitreal injections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endophthalmitis
Keywords
intraocular concentrations of antibiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intraocular antibiotic concentrations determination
Arm Type
Experimental
Arm Description
In the event that the patient develops unfavourably, the ophthalmologist include the patient in the trial. The patient is reviewed at 48 hours after the introduction of probabilistic antibiotic therapy for clinical reassessment and the return of microbiological test results. Following this inclusion, the new samples will be taken when the patient passes through the operating room for the treatment of his pathology as part of the care. Ophthalmologists may have to adapt the patient's management (i.e. adjustment of antibiotic therapy) as part of their usual care routine. An anterior chamber puncture and a vitrectomy are performed. Eye fluids collected as part of the treatment are sent for analysis.
Intervention Type
Other
Intervention Name(s)
Pharmacokinetic and pharmacodynamic study of antibiotics used in severe endophthalmitis from samples taken from treated patients
Intervention Description
A 5mL dry tube will be taken by puncture of the humeral vein like a conventional blood test. This tube is not usually collected unless specifically requested by the ophthalmologist. This sample will be sent quickly (within two hours) to the CHNO Medical Biology Laboratory for centrifugation, serum separation and storage at -80°C. Samples stored at -80°C will be sent weekly to the Microbiology and Anti-infectives Laboratory at Hospital Paris Saint-Joseph, with the dosage request form duly completed with the usual information.
Primary Outcome Measure Information:
Title
Determination of the concentrations of the various antibiotics in the media tested (aqueous and vitreous humours)
Description
Determination of the concentrations of the various antibiotics in the media tested (aqueous and vitreous humours) by liquid chromatography coupled with a high-resolution mass spectrometer (HPLC-HRMS).
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Number of aqueous or vitreous humor samples collected by puncture from treated patients that can be used analytically
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female > 18 years old Francophone Patients referred to emergencies by an ophthalmologist or doctor, or patients already hospitalized, with a unfavourable course 48 hours after introduction of broad spectrum probabilistic antibiotic therapy for the following situations: Cataract surgery Vitreoretinal surgery Intravitreal injection [anti-VEGF for the treatment of AMD, dexamethasone (Ozurdex®) for the treatment of cystoid macular edema] Physical signs presence of intraocular inflammation (Tyndall, hypopyon, cyclic membrane, hyalite) Presence of functional signs (Decreased Visual Acuity) Patients for whom a management re-evaluation is essential with obligation of new intraocular samples. Patient affiliated to social security or, failing that, to another health insurance system Exclusion Criteria: Patient under guardianship or curators Patient deprived of liberty Participation refusal in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François COUDORE, Professor
Organizational Affiliation
Fondation Hôpital Saint-Joseph
Official's Role
Study Director
Facility Information:
Facility Name
Groupe Hospitalier Paris Saint Joseph
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23993357
Citation
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Citation
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PubMed Identifier
23410853
Citation
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Citation
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
Adenis JP, Mounier M, Salomon JL, Denis F. Human vitreous penetration of imipenem. Eur J Ophthalmol. 1994 Apr-Jun;4(2):115-7. doi: 10.1177/112067219400400207.
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Citation
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Citation
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Citation
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Study of Intraocular Concentrations (Aqueous Humor, Vitreous Humor) of Antibiotics After Local and/or Systemic Administration in Endophthalmitis

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